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The primary objective of the trial is to see whether a two-pronged HIV vaccine strategy, ALVAC-HIV (vCP1521) boosted with AIDSVAX B/E gp120, will protect Thai volunteers from HIV infection. The trial is designed to detect a 50 percent reduction in the incidence of HIV infection among vaccines over a three-year period.

A secondary objective is to determine the effect of immunization in controlling viremia and maintaining CD4+ counts should a volunteer become infected with HIV by engaging in risky behavior while in the trial. Both are felt to be indicators of long-term control of disease.

Safety Profile and Composition of the Vaccines

Both vaccines have been studied in thousands of volunteers throughout the world and have excellent safety profiles. It is impossible to get HIV from either vaccine.

ALVAC-HIV (vCP1521) is a live recombinant canarypox vector into which selected HIV genes are inserted. Because canarypox can neither cause disease in humans, nor integrate into the genome, it is attractive as an AIDS vaccine technology. The vaccine targets HIV subtype E, which is most prevalent in Thailand, and will act as the “prime” to the immune system in the study. The canarypox stimulates cellular immunity, by activating cytotoxic T lymphocytes (CTLs), which recognize and kill cells infected with HIV.

VaxGen gp120 B/E (AIDSVAX B/E) is made from a synthetic clone of gp120, a protein found on the surface of HIV. It contains no genetic material. Using recombinant DNA technology, the gene for gp120 is cloned and then duplicated by Chinese hamster ovary cells in commercial-scale fermenters. The gp120 is then purified and mixed with alum, an adjuvant that intensifies the immune response. It too has been designed to target HIV subtype E. AIDSVAX stimulates the humoral immune response, as measured by antibody production.

The hope is that stimulating both arms of the immune system – cellular and humoral – will result in protection against infected cells and freely circulating virus.

Trial Design

The protocol calls for enrolling 16,000 HIV-uninfected volunteers between the ages of 20 and 30 years from Chon Buri and Rayong provinces, in the Eastern Seaboard region of the country. Half the trial participants will receive a dose of ALVAC-HIV (vCP1521) at 0, 1, 3 and 6 months as the “prime” along with a dose of AIDSVAX B/E at 3 and 6 months as the “boost.” The other half of the volunteers will receive placebo injections at all four vaccination visits.

The trial is expected to take two years to enroll. All volunteers will receive individual, extensive counseling on HIV risk reduction. The immunization phase will take six months, with follow-up for three years thereafter. After the vaccination phase, the volunteers will have their blood drawn routinely every six months, to determine whether or not they have become infected with HIV as a result of engaging in risky behavior. All volunteers acquiring HIV infection during the trial will continue to be followed in the study for evidence of continued vaccine safety, and will be treated for HIV according to Thailand national guidelines which include provision of highly active anti-retroviral drug therapy. The trial is expected to conclude in 2009, with final analysis in 2010. There will be one interim efficacy analysis, approximately three years after the start of the trial.

An international Data and Safety Monitoring Board (DSMB) will oversee the trial and conduct at least semi-annual safety reviews.

Multiple Partners, Long-Term Collaboration

Agencies within the Thai and U.S. governments have collaborated for more than a decade in building infrastructure that would support this large-scale efficacy trial. The Technical Subcommittee on AIDS Vaccines, a subcommittee of the Thai National AIDS Commission, and the Ethical Review Board of the Thai Ministry of Public Health (MoPH), approved the trial, along with nine expert panels and Institutional Review Boards in Thailand, the United States and UNAIDS/WHO. Additionally, Thai non-governmental organizations (NGOs) worked with the MoPH on a comprehensive community engagement program.

Trial Update

Screening began on Sept 29, 2003 and the first immunization took place on Oct 20, 2003. As of July 4, 2004 a total of 5,893 volunteers have been screened and 3,435 have been enrolled.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

Walter Reed Medical Centre was conducting HIV Vaccine Trials back a few years ago too. I was enroled when I was 18, but ended up being taken out of the study because I was also bingeing and purging at the time.Hm. Maybe I wouldn't be infected now if I had completed it. Guess I'll never know.

This should be completed about now, I wonder when they will publish any results.

Phase III Trial in Thailand

MHRP is in the follow-up stages in Thailand of the world's largest Phase III study of a complex HIV vaccine candidate. The trial enrolled 16,402 study participants at 50 health centers and hospitals in eight districts.

An Independent Data Safety and Monitoring Board met in July 2007 to conduct an interim analysis of the trial in Thailand. The Board recommended that the study continue, because there were no safety concerns with the vaccine. While no firm conclusions can be drawn from this interim analysis for efficacy of the vaccine, predetermined benchmarks for statistical futility were not met. Study officials expect that the trial will continue until the final analysis, which is scheduled for the summer 2009.

In thailand they have developed an aids vaccine that gives you a third less chance of getting infected thats all i read as it came along the bottom of the screen ,dont know if anyone else has heard about this.

CNN) -- A vaccine to prevent HIV infection has shown modest results for the first time, researchers have found.Researchers found those who received the vaccine combination were 31 percent less likely to contract HIV.

In what is being called the world's largest HIV vaccine trial ever, researchers found that people who received a series of inoculations of a prime vaccine and booster vaccine were 31 percent less likely to get HIV, compared with those on a placebo.

"Before this study, it was thought vaccine for HIV is not possible," Col. Jerome Kim, who is the HIV vaccines product manager for the U.S. Army, told CNN.

Kim emphasized that the level of efficacy was modest, but given the failures of previous HIV vaccine trials, "yesterday we would have thought an HIV vaccine wasn't possible."

He called the results from the trial an important first step that will help researchers work toward a more effective vaccine.

Researchers have tried to prevent the spread of HIV since they discovered its cause in 1986. Previous vaccine trials failed to prevent infection. And during one trial, the vaccine seemed to boost the chance of being infected, which ended testing early.

The new study was conducted in Thailand, with more than 16,000 people between ages 18 and 30 participating. They were all HIV negative at the beginning of the trial.

Nearly 8,200 received a placebo and a similar number received a combination of six vaccines over six months. All were followed for three years.Don't Miss

* Learn more about HIV/AIDS

"This shows a statistically significant effect," Kim said.

He cautioned that a lot more research was necessary, because the vaccine did not prevent everyone from being infected.

Fifty-one people in the vaccine group eventually contracted HIV, compared with 74 in the placebo group.

"These results show that development of a safe and effective preventive HIV vaccine is possible," said Col. Nelson Michael, who is director of the U.S. military HIV research program.

The combination of vaccines tested targeted strains circulating in Thailand. It was unclear how the vaccines would work elsewhere, Kim said.

Researchers will announce details of their initial findings in October at the AIDS Vaccine Conference in Paris, France.

The study was funded by the National Institutes of Allergy and Infectious Diseases and the U.S. Army Medical Research and Materiel Command.

According to Kim, the U.S. military was involved in the study because U.S. service members are at risk and "there's a national security threat from HIV."

He said Congress set up a program to protect service members from HIV and the U.S. military has collaborated with health officials and researchers in Thailand for a long time.

The vaccines are manufactured by Global Solutions for Infectious Diseases and Sanofi Pasteur. The Thai Ministry of Health carried out the clinical trial.E-mail to a friend E-mail to a friendShare this on:Mixx Facebook Twitter Digg del.icio.us reddit MySpace StumbleUpon| Mixx it | Share

I was happy to merge your thread from Living into this thread in Research, as it gave me the opportunity to change the title of the thread without having to edit Tommy's post.

People, PLEASE, when posting new threads here in the Research Forum, give your thread a title that accurately describes what it's about. Use the name of the trial (or study), as I have. This makes it easier for us to keep subjects in one thread, without having three or four threads about the same research news.

Thank you all for your cooperation. And remember, this request is to make it easier for EVERYONE to find the information they're interested in. Cheers.

Ann

ps - I've edited the posting guidelines in our Research Forum's Welcome Thread to include this thread-naming request.

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

This find could definitely be a breakthrough toward a vaccine that will do more than the 31% that this vaccine protected in the trial. Even though the vaccine does not work in those already infected, what they learn from this vaccine could move things forward on all fronts.

Never give -up Hope!v

Absolutely...the importance of this milestone is that it shows that it can be done, and they are on the right track. Hopefully other researchers will hone in on this as well, and work together to develop it further!

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

GeoVax Labs Inc. greeted warmly the news on Thursday of the partial success in Thailand of a candidate HIV/AIDS vaccine owned by Sanofi-Aventis and Global Solutions for Infectious Diseases.

GeoVax (OTC BB: GOVX), an Atlanta-based HIV/AIDS vaccine developer, said the Thailand study represents the first HIV/AIDS vaccine trial to show prevention of infection and supports GeoVax’s strategy. The trial included 16,000 volunteers and was supported by multiple agencies including the U.S. Army and the U.S. National Institutes of Health (NIH).

"The partial success of this trial is very important to the GeoVax vaccine, because the vaccine tested in Thailand, like the GeoVax vaccine, was designed to elicit both T cells and antibody," said Dr. Harriet Robinson, GeoVax senior vice president of research and development, in a statement. "The two vaccines that have failed in previous efficacy trials elicited only antibody or only T cells. This was the first efficacy test of a vaccine that elicited both antibody and T cells and is very encouraging for the GeoVax vaccine, because our vaccine generates higher frequencies of T cells and better quality antibody.”

Robinson added that what GeoVax knows about the elicited responses observed in the Thailand study, and the similarities and differences between its vaccine and the Sanofi-Aventis vaccine, the GeoVax vaccine should be poised for a higher level of protective success than the 30 percent success rate in Thailand.

How much money went into curing Polio after Jonas Salk invented the polio vaccine? I don't want to downplay the importance for everyone else but if you think funds, and great minds, will continue to be drawn they way they are now, to a search for a "cure" after an effective preventative vaccine is found, then you are the one who is dillusional.

The posts in this forum are often ridiculously optimistic even when there is little or no reason to be. Just because I won't drink the kool-aid doesn't mean I'm dillusional. This is a website for people with HIV. A preventative vaccine that doen't help the infected is not fabulous news for the infected the same way the polio vaccine was not great news for those already afflicted.

If you don't think that once a preventative vaccine is found that there won't be an enormous shift of money and minds out of the search for a cure, then you're not thinking clearly.

I have many friends who are negative and I want them to stay that way. So for that reason this is great news for them and humanity. But selfishly for us on the website - not so much.

« Last Edit: September 24, 2009, 11:50:58 AM by bmancanfly »

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"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

I know better than to be overly critical of another's posts lest I incur the WRATH OF ANN, but that post is lame, pessimistic, and simply delusional. You base your conjecture on what exactly?

Free,

Critisizing someone's post (ideas, opionions) in a respectful manner is one thing - and allowed. However, critisizing the poster personally, as in name-calling or otherwise disrespecting them is what is NOT allowed. I hope you can see the distinction.

I happen to agree that Bman's opinion of this being bad news for us is misguided and overly pessimistic. This advanced is welcome news for everyone, for many reasons.

See, now that is exactly the kind of distinction I'm talking about. Free said your post, in other words, your opinion, was lame, pessimistic, and simply delusional. He didn't say YOU were. There is a difference. A person can be totally rational, yet hold an opinion or two which seem delusional to others. Get it?

There is every reason for those of us who are already poz to be happy about this news - for ourselves. It's a breakthrough of the type which may lead to a theraputic vaccine for US. In no way does it make me think they'll stop looking for a cure or better treatments just because of this development. Quite the contrary, many scientists are somewhat competitive and this may light the fire under a few labcoat covered butts.

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

yes a preventive vaccine is not good news for us already infected,it will only make us completely forgotten in no time.and the only thing we would see from pharma companies is new HAART with vanilla,chocolate,or strawberry flavors !

This is great news for the HIV negative and aweful news for us pozzies. Once there is a preventative vaccine you can say goodbye to any meaningful energy going into a cure.

I don't think most of us are going to see a cure in our lifetime anyways. If you think about it, if they got a preventative vaccine death would become a natural cure to HIV once the infected people naturally died off, and then people would be vaccinated against HIV and would not catch it. That would be a cure for this epidemic. Sad, but death kinda has a natural way of curing things.

« Last Edit: September 24, 2009, 12:45:47 PM by MYSTERY »

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Atheist don't believe in GOD, but GOD believes in them and loves them. Never let the failure of man conflict with your love of GOD.

yes a preventive vaccine is not good news for us already infected,it will only make us completely forgotten in no time.and the only thing we would see from pharma companies is new HAART with vanilla,chocolate,or strawberry flavors !

I don't think most of us are going to see a cure in our lifetime anyways.

Wow, the pessimism here is deafening. Please explain and elaborate a bit on this point. If it's solely based upon how you "feel", it's nothing more than an unsupported assertion. My optimism is based on the ever increasing rate of technology and advances in areas not even in existence 10 years ago (plotting the genome, gene manipulation, gene silencing, medications with little to no side effects, identification of the reservoirs where HIV hides and advances towards eradication of these, etc).

The so-called German Patient was cured. So in essence we've already seen a cure in our lifetime. It's called proof of principle. Whether technology will enable researchers to duplicate what was done there in a less invasive and dangerous way isn't known yet. However, given the rate of discovery and new technology, I know I'm not betting against it.

yes a preventive vaccine is not good news for us already infected,it will only make us completely forgotten in no time.and the only thing we would see from pharma companies is new HAART with vanilla,chocolate,or strawberry flavors !

You are wrong any vacine to stop people getting infected would mean they are on the right track and will lead to other breakthroughs .

Let me give you my take as to why this vaccine advance is not only great news for the HIV-, but also for the HIV+.

For a vaccine to be viable (ie: accepted by the FDA) , the vaccine needs to be at least 70-80% effective against the pathogen. While the Geovax vaccine came in at 31%, a preventative vaccine will have to be a lot more potent. 31% is something that has never been done, but there are still many questions unanswered. They need something else to stimullate a strong enough immune response.What are the options:1. Increase the dosage?2. Are the antibodies being made strong enough to do the job for everyone?3. Are there any consequences to the above?4. Could they add more potent neutralizing antibodies ?5. How many of the trial participants adhered to the safe sex talk given to them after vaccination?6. Will the percentages go up or down over a longer period of time?7. Could something be added to the vaccine to stimulate B-cells' production of the "right" kind of antibody that will not only prevent infection, but also control it? (a two-for one)? ......Think of somemore what-ifs.

Still a lot of work to be done and more breakthroughs to be found. For those that think science will stand still after a preventative is found ( if a preventative is found first) think of this: There are more than 30 million people infected with this virus world wide. The strain on healthcare systems around the world is immense just to control the virus itself let alone the AEs and OIs. This is unsustainable. Besides, a patient population of 30 million is a huge insentive enough for the work to go on.The work will continue on all fronts !!!!!!

I have to admit that, although I am totally gun-ho about vaccine development and watch the studies closely, part of me would really like to see a successful cure or therapeutic vaccine BEFORE the eventual truly successful preventative comes out. I know it's paranoid..but I can't help but agreeing somewhat that there is some truth to the idea that funding and interest will gradually shift away from treatment, once a successful vaccine is in place. That said - one of the reasons I am still so pro-vaccine research is that because of the way HIV works on the immune system, any truly effective preventative is more than likely to work therapeutically as well, perhaps with a few tweaks, which does help me sleep at night (fortunately I'm not on Sustiva, so I don't have giant, flying vaccine needles attacking me in the middle of the night).

One little correction - veritas, the Thai vaccine is not Geovax. Geovax simply commented and 'congratulated' the Thai results, as a way of pointing out that THEIR vaccine is similar but better. I'm sure it was completely altruistic, especially since their stock volume went from an average of 400K to 8M and jumped by 50% after the comments.

Ok and am I missing something, but out of 16,000 (!!) people 51 vs 74 went poz? Is this really statistically significant? Please tell me I am...

While the media loves a big story, these results were underwhelming. Although they were "statistically significant," it is way too early to declare success. A simple look at the numbers is more sobering: after vaccinating 16,000 people, there were 23 fewer new infections in patients receiving the vaccine (51 cases versus 74 cases). If one additional patient who received the vaccine became infected (52 instead of 51) the results would no longer be "statistically significant."

A misunderstanding of statistics and study design often leads to premature optimism as well as fear, when new studies come out. Today we learned that a combining multiple injections of two vaccines that proved unsuccessful in the past may reduce the chance of new infections. I remain hopeful but VERY skeptical, given the modest differences and lack of biological evidence (there was no difference in viral loads between vaccinated and non-vaccinated patients who acquired HIV). While I am encouraged by the efforts and work being done to develop a vaccine, we have yet to find a silver bullet.

Ok and am I missing something, but out of 16,000 (!!) people 51 vs 74 went poz? Is this really statistically significant? Please tell me I am...

Results: New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 percent lower risk of infection for the vaccine group.

I'm not a statistician but I thought the same thing: how can this be "statistically significant"? (Thanks, Miss P for the article with the 4-1-1 on the math). I'm just wondering if they were very careful to control for high-risk groups (MSM, sex workers, injection drug users) to be evenly distributed between the two groups, otherwise you've got some skewed results.

I read two contradictory descriptions of those who participated in the trial:

One article (pittsburghlive.com) said: The study tested the combo in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected.

But another article (reuters.com) said: The trial was organized by the Thai government and military, who recruited 16,000 ordinary people considered at "community risk" of getting HIV. "What we mean by community risk is that we would include everyone in the community," Kim said. That includes a few commercial sex workers, men who have sex with men and perhaps injecting drug users -- all of whom would be considered at high risk of HIV. But many ordinary people at no extra risk also took part.

The way I see it the only way the results can be valid is if the higher risk individuals were evenly distributed between the two groups.

Who knows, in a few weeks' time we may be seeing another article saying "Woops! Maybe this vaccine didn't work after all" since one group had too many drug addicted gay whores!

Yes , this is a first truly reliable great news in a past few years .But it raises a dozen of questions :

1.The vaccine is only 30 % effective , and with a HIV strain present in Thailand.What kind of virus part make it ineffective on the other 70 % , and what would be if that kind of vaccine is implemented on HIV strains in other parts of the world - Africa and Europe ?

( For the vaccine to be effective a minimum percentage is 98-99 , and it could be achieved if scientist could find a part of virus that is unchangeable and vulnerable and make a vaccine as aresult of those two facts.)

2.The vaccine is preventive type not a therapeutic one.Also a latest report from pharma companies stated that they put a little effort to find a new drugs with less side-effects.Is that mean that all of us are going to be " left with the flood" ?

3. Is there a way to convert that kind of vaccine into therapeutic one ?Is there is a possibility for all 7,000 , and more of us in POZ .com to make any kind of petition to a certain U.S army.Drug company ?

And I must admit that I feel sorry for those poor people who has volunteered to be infected with HIV even with a government guaranties for their HAART treatman.

And I must admit that I feel sorry for those poor people who has volunteered to be infected with HIV even with a government guaranties for their HAART treatman.

No one volunteered to be infected with HIV. Both groups were given counseling and plenty of condoms and were told to play it safe etc. When you've got 16,000 people there are those who will still slip up and fall off the wagon.

The vaccine, if it is proven to be effective, does appear to work against the main strain found in the US & Europe, which is clade B. That's no consolation to those in Africa and other poor areas but just saying, it's not just the strain found in Thailand.

First-Ever Protective Effect Is Small but Suggests HIV Vaccine Is Possible

By Daniel J. DeNoonWebMD Health News

Reviewed by Louise Chang, MD

Sept. 24, 2009 - "Modest" success in an HIV vaccine trial shows for the first time that vaccination can protect people against infection with the AIDS virus.

It's a small but significant step forward. Few, if any, think this vaccine is effective enough to deploy in the worldwide fight against AIDS. But many experts say it offers badly needed hope to an effort marked by many expensive failures.

"While these results are encouraging, we recognize that further study is required to build upon these findings," Col. Nelson Michael, director of the U.S. Military HIV Research Program, says in a news release.

The trial was a collaboration between the U.S. Army, Thailand, the U.S. National Institute of Allergy and Infectious Diseases, Sanofi Pasteur, and Global Solutions for Infectious Diseases. It tested Sanofi's ALVAC vaccine boosted with a dose of GSID's AIDSVAX.

Conducted in Thailand, it began in 2003 and enrolled 16,402 adult, HIV-negative men and women. Half got the two-part vaccine, and half got inactive placebo shots.

Over the course of the study, 74 placebo recipients and 51 vaccine recipients became infected with HIV. The difference isn't large, but it translates into 31% vaccine effectiveness. That is, it lowered the risk of getting HIV by 31%.

Even so, the study results are puzzling. It was expected that vaccine recipients who became infected would at least have some protection against the virus. But the study found no evidence of such protection. HIV levels were just as high in vaccine recipients who became infected as in placebo recipients who contracted the virus.

Perhaps more importantly, the study fell far short of its goal of reducing the risk of HIV infection by 50%.

The study was controversial from the outset. It's the largest HIV vaccine trial yet conducted, and some AIDS activists called the study a waste of precious resources.

AIDSVAX, the first HIV vaccine ever to be tested, had already failed to prevent HIV in a number of trials. ALVAC, a live canarypox virus carrying HIV genes, did not appear to stimulate strong immune responses in healthy people. And similar combination vaccine strategies showed little evidence of eliciting strong immune responses.

Moreover, a similar study of the ALVAC and AIDSVAX vaccines had been canceled in the U.S. And critics said the study design would make it hard to tell which part of the vaccine regimen was or was not effective.

Now that the study is completed, researchers will go over the data with a fine-tooth comb. They'll try to figure out what worked and build on that success.

"Knowledge gained through this study will be used to accelerate future study design and testing as researchers continue the search for a safe, globally effective HIV vaccine," Col. Jerome Kim, HIV vaccines product manager for the U.S. Army, says in a news release

Thanks for the correction to my post. You are correct it is not Geovax ---- my error for not having my brain and typing skills in cync. (lol).

Miss Philicia,

I think we are all in agreement that this particular vaccine is not the silver bullet. The statistics are only good for the time alottted (a point in time). Next week two or more people from the vaccinated group could become infected and the stats change. However, for this study design and time those were the statistics and thats the first time that type of result was found with HIV. There's a long way to go. Let's wait to see the data review, hopfully completed by the Paris conference.

Inch,

I hope we don't get that "WHOOPS" also but it is a possibility. Usually when atrial like this is set-up it is blinded so no-one knows who is getting the vaccine and who is getting the placebo. It should all be by chance so the statistics should be valid ( again data review needs to be done). I hope they didn't cheat!

SASA,

I don't believe a vaccine has to be 98 or 99% to be approved or effective. Take the Guardicil vaccine --that is only 93% in women and their about to approve it for men:

A 70 or 80% effective vaccine for HIV would put a dent in the epidemic.

They have found non-mutatable parts of the virus --- the trick is to mount a strong enough immune response and get to the latent cells for a cure or get to all freeflowing virus by some type of adaptive immunity so our immune systems can at least control the freeflowing virus -- work on the aforementioned is being done.I thought the news was a step in the right direction.

Who knows, in a few weeks' time we may be seeing another article saying "Woops! Maybe this vaccine didn't work after all"...

Actually I was thinking this over, and frankly I would not be surprised this could turn out to be the case. I mean, if in fact the vaccine did prevent some infections, then yes, it is a great step forward. But...

There was only a difference of 23 non-infections in the vaccinated group, compared to the placebo. And this is out of 8197, so this is mighty small....how do the researchers really know that the lower number in the vaccinated group was really the result of the vaccine? Especially when they saw no therapeutic benefit whatsoever in the vaccinated arm among those that did get infected?? Hmmm.

As far as I'm concerned this small difference could have been anything, and we cannot rule out it was the result of pure chance in the vaccinated group, perhaps different behaviour, maybe even a difference in the pre-trial counseling that was provided to the two different arms, who knows?

Hope I'm wrong, obviously, but I will revise my earlier optimism and reserve it for a little further down the line until they can analyze this data more rigorously.

« Last Edit: September 25, 2009, 01:18:43 AM by J220 »

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

I hope we don't get that "WHOOPS" also but it is a possibility. Usually when atrial like this is set-up it is blinded so no-one knows who is getting the vaccine and who is getting the placebo. It should all be by chance so the statistics should be valid ( again data review needs to be done). I hope they didn't cheat!

I don't think they cheated I'm just saying that with some high risk groups, for example MSM there are men on the DL who don't admit to having sex with other men, or people who are sex workers or IV drug users who also don't admit to it. If individuals from the high risk groups were not evenly distributed between the two arms (without the researchers even realizing it) then the results would be skewed one way or the other.

Bottom line is they will be looking at this data with a fine tooth comb, I think it's too soon to really know what the numbers mean.

Actually I was thinking this over, and frankly I would not be surprised this could turn out to be the case. I mean, if in fact the vaccine did prevent some infections, then yes, it is a great step forward. But...

There was only a difference of 23 non-infections in the vaccinated group, compared to the placebo. And this is out of 8197, so this is mighty small....how do the researchers really know that the lower number in the vaccinated group was really the result of the vaccine? Especially when they saw no therapeutic benefit whatsoever in the vaccinated arm among those that did get infected?? Hmmm.

You're right, these results are a hair's breadth from not being "statistically significant." All of these studies rely on statistics and the fact that 51 people in the arm that received the vaccine got infected made these results "statistically significant." As the article that Miss P cited said, if just one more person had been infected to make it a total of 52, then the results would not have been considered statistically significant. So this is pretty darn close.

I think the excitement comes from the fact that these results are so much better than any previous attempt with an HIV vaccine so some researchers and people who follow this were expecting much worse numbers and the results ended up surprising everyone.

Regarding the statistical significance of the trial results (source:aidsmap)

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In the event, the prime-boost combination of ALVAC(R) HIV and AIDSVAX(R) B/E lowered the rate of HIV infection by 31.2% compared with placebo. This reduction was statistically significant, meaning that the possibility that the possibility of the result being due to chance is very low, but the confidence intervals for the estimate in the reduction in risk were wide (p=0.039, 95% confidence interval 1.1% - 51.1%).

So while it's true that the results are technically "statistically significant", I think they warrant further study. Especially, taking into account there was no reduction in the mean viral load between those who received the vaccine and still were infected and the infected ones who got the placebo. IMHO, assuming the vaccine really worked, this could mean either that this vaccine approach only works as preventive one (and once the single virus that is supposed to originate most transmissions manages to break the defenses elicited by the vaccine, it has no effect), either there is something more we do not still comprehend about the way the immune defense works with hiv. To sum up: what I said before about studying this further :-)

Anyway, even if this approach leads to a preventive only vaccine, I believe it's also good news to us. Not only because any scientific advance in the field may contribute to an eventual, functional or otherwise, cure, but also because a truly preventive vaccine would do lots about reducing stigma and poz-fear, and that nowadays is a great part of the burden hiv imposes to us.

But one thing still puzzles me :If volunteers were divided into two groups - one with placebo and one with vaccine , and it had been told them to practice safe sex , then how after a few years researches knew if they had practiced safe sex , sex at all , or they were sex workers who practiced unsafe sex frequently every day ?Who monitored them , because at the questioning they could tell anything they wanted to ?

And for veritas : with this kind of tramsmission , my opinion is that effectiveness of the vaccine should be more than 95 % , because that will be the way to stop spreading.Al

I agree with you, I do hope they come up with a vaccine that is 95,98 or 99% effective. However, my post meant to show that the FDA would welcome a vaccine that rendered protection to 80% of the population and such a vaccine would put a dent in the epidemic.

I don't think that anyone following my posts can put me in the category of pessimists. I'm following research and development because I believe research is on the cusp of a major breakthrough. Let me reiterate, my interest in anti-ps is based on the fact that flipped PS is a non-mutatable part of both the virus and infected cells. If they find a way to deliver a potent enough immune response to that target then we have the potential for both a cure and a vaccine. Millions of dollars and hundreds of researchers are involved in developing anti-ps research since it is a common target for many viruses, bacterior and cancer. The "holy Grail" if found. So believe me when I say "we're on the same page."

Also, let me say, if someone finds another pathway to a cure , I'll hail that also. The work is progressing on many fronts, the race goes on and it's happening!

Everyone: If people are told they are getting this anti-HIV vaccine won't they think they are protected and engage in riskier sexual activities than before? Reminds me of circumcision campaigns (to combat HIV and other STDs) in S. Africa (among other areas of the world). Do you think those guys use a rubber after being told they have participated in an HIV reduction/prevention measure? Doubt it.

Medically this vaccine news is exciting (if it eventually leads to a 99%+ successful vaccine). Socially, it's a dud.

Everyone: If people are told they are getting this anti-HIV vaccine won't they think they are protected and engage in riskier sexual activities than before?

Perhaps to a degree, but remember, the volunteers were simply told they were receiving either the placebo or the vaccine, but not which one. So they did not know for sure they got the vaccine, and furthermore, if the vaccine was going to work. But I can see how someone would think that there is a 50% chance they received the vaccine...and another chance the vaccine woud work, and have this influence their behaviour. In fact this was on NPR yesterday and they had an excellent disussion about the complex ethics of vaccine trials.

Logged

"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

In terms of vaccine and other prevention measure development, most of the clinical trials networks have thus far done an excellent job of ensuring that the overall risk-taking has actually gone down in stuides- and not up. This has been achieved through extensive counseling and education, provision of condoms, etc. The CDC and other stakeholders have taken an extremely responsible position on this issue as the way they are talking about things like PrEP. They say that no matter how successful a new prevention tool might be, it must be used in combination with all other proven prevention methods - that what we're shooting for is a prevention package.

Granted, this won't ensure that additional risk never happens if someone perceives themselves to be protected by whatever becomes available (PrEP, microbicide, vaccine), but the CDC does plan to issue strong recommendations about proper prevention counseling to be conducted along with prescriptions for anything that ultimately proves effective.

In terms of hopes or skepticism about these results, it seems that here are valid reasons for both. The traditional press usually glosses over complexity and this is a perfect example where the results are not at all straightforward. The complete data have not been provided thus far, so it's very difficult to determine how compelling these results are going to be. It seems there is at least a possibility to learn more about the mechanics of protection from infection, and then use those learnings toward more promising vaccine approaches. That would be great.

I also want to reassure you that groups like Project Inform, ATAC and others are doing everything we can to make sure that the search for a cure for people who are already positive doesn't fall off of the agenda. Before he died, the activist Martin Delaney was successful at getting the NIH to coordinate and devote additional resources to this end. There's still a LOT we still need to learn on a basic science level about the immune system and viral reservoirs, but progress is being made. I hope people don't give up all hope.

Bravo !!! A good even-keeled response to a story that certainly can be sensationalised by the main stream media with the main point being drowned in the hype.

What stood out for me was Fauci's comments:

"These new findings represent an important step forward in HIV vaccine research,” says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, which provided major funding and other support for the study. “For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field"

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

I also want to reassure you that groups like Project Inform, ATAC and others are doing everything we can to make sure that the search for a cure for people who are already positive doesn't fall off of the agenda.

I wanted to repeat what David said above because it's relevant to some of the Research forum regulars. Those of you who are adamant that the search for a cure - or even better treatments - will cease with the development of a vaccine might want to think about joining one of the advocacy groups. Sitting at home, wringing your hands and bemoaning the fate of us pozzies should a vaccine be found will achieve absolutely nothing. Getting involved in an advocacy group will achieve something and we have plenty of examples in the history of hiv/aids to show just how true this is.

Don't just sit there, DO something! We need a new generation of activists. And we need them NOW.

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts